85/100 · Critical
Manufactured by Novartis Pharmaceuticals Corporation
Mycophenolic Acid Adverse Events: High Seriousness and Diverse Reactions
51,116 FDA adverse event reports analyzed
Last updated: 2026-05-12
MYCOPHENOLIC ACID is a medication tracked in the FDA Adverse Event Reporting System (FAERS), manufactured by Novartis Pharmaceuticals Corporation. Based on analysis of 51,116 FDA adverse event reports, MYCOPHENOLIC ACID has a safety score of 85 out of 100. This score indicates a relatively favorable safety profile, with fewer or less severe adverse events compared to many other tracked medications. The most commonly reported adverse reactions for MYCOPHENOLIC ACID include OFF LABEL USE, DIARRHOEA, DRUG INEFFECTIVE, DEATH, PYREXIA. This page provides a comprehensive breakdown of reported side effects, safety signals, patient demographics, and AI-powered safety analysis for MYCOPHENOLIC ACID.
Mycophenolic Acid has a safety concern score of 85 out of 100, placing it in the high concern category based on analysis of FDA adverse event data. The FDA has received approximately 51,116 adverse event reports for this medication, which is primarily manufactured by Novartis Pharmaceuticals Corporation.
The most commonly reported adverse events include Off Label Use, Diarrhoea, Drug Ineffective. Of classified reports, 87.8% were designated as serious by the FDA, meaning they involved hospitalization, disability, or other significant medical outcomes. High percentage of serious adverse events (87.8%) indicates significant safety concerns.
Diverse range of reactions, including kidney injury, infections, and immunosuppression issues. Significant report volume (51,116) supports the reliability of the data.
Patients taking Mycophenolic Acid should monitor for the commonly reported side effects and contact their healthcare provider if they experience any unusual symptoms. Mycophenolic acid can cause drug interactions, and patients should be warned about potential interactions with other immunosuppressants. This analysis is based on voluntary FDA adverse event reports and should not replace professional medical advice.
Mycophenolic Acid received a safety concern score of 85/100 (high concern). This is based on a 87.8% serious event ratio across 30,170 classified reports. The score accounts for 51,116 total adverse event reports and 100 distinct reaction types. This high score reflects a significant proportion of serious adverse events in the reporting data.
Adverse event reports by sex: Male: 14,510, Female: 12,748, Unknown: 117. The most frequently reported age groups are age 64 (557 reports), age 63 (547 reports), age 65 (534 reports). These demographics reflect reporting patterns and may not represent the full patient population.
Out of 30,170 classified reports for MYCOPHENOLIC ACID:
The FDA classifies an adverse event as “serious” if it results in death, hospitalization, disability, congenital anomaly, or requires intervention to prevent permanent damage.
Demographics reflect voluntary FDA adverse event reporting patterns and may not represent the full patient population.
Mycophenolic acid can cause drug interactions, and patients should be warned about potential interactions with other immunosuppressants.
If you are taking Mycophenolic Acid, here are important things to know. The most commonly reported side effects include off label use, diarrhoea, drug ineffective, death, pyrexia. While many of these may be mild and temporary, you should contact your healthcare provider if any symptoms are severe or persistent. Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosing instructions and do not alter the dose without medical advice. If you experience a serious adverse reaction, seek emergency medical attention immediately or call 911. You can report side effects to the FDA's MedWatch program at 1-800-FDA-1088.
The FDA closely monitors Mycophenolic Acid due to its high serious event rate, and ongoing reviews are necessary.
The FDA has received approximately 51,116 adverse event reports associated with Mycophenolic Acid. These reports come from healthcare professionals, consumers, and manufacturers through the FDA Adverse Event Reporting System (FAERS). Note that the number of reports does not directly indicate the frequency of side effects, as adverse events are voluntarily reported and may be underrepresented.
The most frequently reported adverse events for Mycophenolic Acid include Off Label Use, Diarrhoea, Drug Ineffective, Death, Pyrexia. By volume, the top reported reactions are: Off Label Use (2,638 reports), Diarrhoea (1,884 reports), Drug Ineffective (1,714 reports). These figures reflect FDA adverse event reports and may not represent the true incidence rate of these side effects in all patients taking Mycophenolic Acid.
Out of 30,170 classified reports, 26,479 (87.8%) were classified as serious and 3,691 as non-serious. The FDA classifies an event as "serious" if it results in death, hospitalization, disability, or other medically significant outcomes. A higher serious-event ratio warrants closer attention but does not necessarily mean the drug is unsafe.
Adverse event reports for Mycophenolic Acid break down by patient sex as follows: Male: 14,510, Female: 12,748, Unknown: 117. This distribution reflects reporting patterns rather than actual risk differences between groups. Reporting rates can be influenced by prescribing patterns, disease demographics, and reporting behavior.
The most frequently reported age groups for Mycophenolic Acid adverse events are: age 64: 557 reports, age 63: 547 reports, age 65: 534 reports, age 59: 532 reports, age 60: 511 reports. Age-related reporting patterns can reflect both the demographics of the patient population and potential age-related susceptibility to certain side effects.
The primary manufacturer associated with Mycophenolic Acid adverse event reports is Novartis Pharmaceuticals Corporation. Multiple manufacturers may produce generic versions of this drug. The manufacturer listed reflects the most frequently reported brand in FDA adverse event data.
Beyond the most common reactions, other reported adverse events for Mycophenolic Acid include: Acute Kidney Injury, Nausea, Covid-19, Fatigue, Vomiting. Less common side effects can still be clinically significant. Patients should report any unusual symptoms to their healthcare provider.
You can report adverse events from Mycophenolic Acid to the FDA through their MedWatch program at www.fda.gov/medwatch, by calling 1-800-FDA-1088, or by completing Form FDA 3500. Healthcare professionals, consumers, and manufacturers can all submit reports. Reporting helps the FDA monitor drug safety after approval.
Mycophenolic Acid has a safety concern score of 85 out of 100 (high concern). This score is calculated from the ratio of serious to non-serious adverse events, the diversity of reported reactions, and the overall volume of reports relative to usage. High percentage of serious adverse events (87.8%) indicates significant safety concerns.
Key safety signals identified in Mycophenolic Acid's adverse event data include: Acute kidney injury and renal impairment are frequent and serious adverse events.. Multiple reports of infections, including pneumonia and cytomegalovirus infection.. High incidence of drug interactions and ineffective drug performance.. These signals are derived from patterns in FDA reports and should be discussed with a healthcare provider for personalized assessment.
Mycophenolic acid can cause drug interactions, and patients should be warned about potential interactions with other immunosuppressants. Always inform your healthcare provider about all medications, supplements, and over-the-counter drugs you are taking before starting Mycophenolic Acid.
Patients should report any new or worsening symptoms to their healthcare provider immediately. Follow prescribed dosing instructions and do not alter the dose without medical advice.
Mycophenolic Acid has 51,116 adverse event reports on file with the FDA. Diverse range of reactions, including kidney injury, infections, and immunosuppression issues. The volume of reports for Mycophenolic Acid reflects both the drug's usage level and the vigilance of the reporting community.
The FDA closely monitors Mycophenolic Acid due to its high serious event rate, and ongoing reviews are necessary. For the most current regulatory information, check the FDA's drug labeling database or consult your pharmacist.
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